FDA Decision to Recall Meridia Came Too Late for Some: Public Citizen

The prominent consumer advocacy group Public Citizen is criticizing the FDA over how long it took the federal drug regulatory agency to recall Meridia, a prescription weight-loss drug that has been linked to an increased risk of heart attacks and strokes. The FDA may have cost countless lives by waiting years after evidence showed that there was an unacceptable risk of heart problems with Meridia, according to Public Citizen.

Meridia (sibutramine), which was manufactured by Abbott Laboratories, was first approved by the FDA in 1997 as a prescription-only weight loss supplement for obese patients with other risk factors such as diabetes, high cholesterol and controlled blood pressure. On Friday, the FDA announced that the drug would be recalled due to an increased risk of cardiovascular problems, while providing very little actual weight loss benefit for consumers.

Public Citizen, a non-profit organization focused on consumer protection, said in a press release that the FDA should have heeded its earlier calls for a recall of Meridia. The group first called for Meridia to be banned in 2002, after identifying a growing number of post-marketing cases of heart attacks among relatively young patients with no other explanation. After the FDA denied the 2002 petition, Public Citizen re-petitioned for Merdia to be recalled in December 2009.

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“Since (the original 2002 petition), more than 3 million prescriptions have been filled for Meridia, with many patients inevitably having had heart attacks or strokes because of its known toxicity,” said Dr. Sidney Wolfe, Direct of Public Citizen’s Health Research Group. “Even since January of this year (after our December 2009 re-petition to ban the drug), when the European Medicines Agency decided to withdraw the drug from Europe, there have been more than 160,000 prescriptions filled for Meridia in the U.S.”

Late last year, the findings of a clinical trial called SCOUT found that Meridia increased the risk of serious heart events, such as heart attacks and strokes, by 16%, while finding only a small difference in the weight loss between people given Meridia and those given a placebo. The FDA said that the SCOUT data and the agency’s subsequent review led it to the decision to ask Abbott Laboratories to remove Meridia, which it reluctantly has agreed to do.

Public Citizen said that the health risks of Meridia have been obvious for years, and that the same pre-approval clinical trials which led to Public Citizen’s first petition were available to the FDA, and had raised concerns as early as 1997 from FDA advisory committees and drug reviewers. However, the non-profit group accuses the FDA’s Office of New Drugs (OND) of interfering with the Office of Surveillance and Epidemiology (OSE), which had been recommending a Meridia recall for some time. OND also overrode OSE’s recommendations for an Avandia recall, Public Citizen claims.

Public Citizen’s concerns over the OND’s ability to prevent OSE from doing its job have been echoed by some lawmakers, and there have been suggestions that any congressional FDA reforms include ensuring that the OSE can operate without fear that the OND can override its decisions.

Although Abbott did agree to recall Meridia late last week, they have fought hard to keep the drug on the market. The drug maker released a statement on Friday indicating that they disagree with the FDA’s decision, but will comply.

8 Comments

  • raghdaNovember 10, 2010 at 12:14 pm

    i strongly agree that such pills are for short term use only , until u can control your diet and eating habits , i used to use them for only few day every now and then to adjust my diet and then i pull back for really long months ... now i need such pills , anybody knows any other pills with the same effect ?

  • steveOctober 26, 2010 at 6:50 pm

    Bravo to Carmen for "geting it"--these meds are not meant to "make you lose weight," but to "help you lose weight." The onus is on the overweight to make the lifestyle changes to become sudccessful. Shame on Public Citizen and Dr. Wolfe--another good medicine taken off the market for their self-serving benefit. Here's my analogy to Forrest's (and others like him) argument of cause and effect: I[Show More]Bravo to Carmen for "geting it"--these meds are not meant to "make you lose weight," but to "help you lose weight." The onus is on the overweight to make the lifestyle changes to become sudccessful. Shame on Public Citizen and Dr. Wolfe--another good medicine taken off the market for their self-serving benefit. Here's my analogy to Forrest's (and others like him) argument of cause and effect: I wake up every morning and the sun comes up every morning, so obviously I make the sun come up. 100% correlation in my "scientific analysis!" The FDA needs to stop allowing itself to be bullied into making decisions based on bad science--they do have some legitamacy and authority to buck the lawyers if they would only have the backbone to do so.! Meridia has been safe and effective in my practice (a physician with satisfied and grateful patients), and I have heard of NO conclusive correlatation with bad outcomes in the many years it has been on the market. Shame on all of you---again. (I'm sure it is justa matter of time until all the childhood vaccines are removed from the market!)

  • LisaOctober 25, 2010 at 1:23 pm

    I took Meridia for about 5 months, 4 years ago. I lost 40 pounds, and had no side effects from the med. It was the first "diet pill" that I have found that didn't make me feel jittery, etc. And it worked for me! I just started back on the med because I wasn't watching my diet and have put weight back on. Sorry to see it pulled from the market. But, better safe than sorry.

  • CarmenOctober 23, 2010 at 5:59 pm

    First off, this is not a "take it a year" diet medicine! I took it 7 years ago for 3 months, lost over 50 pounds and had just started back on it, due to putting some of it back on from lack of watching my own diet. The goal behind this diet pill is for short term use. I fail to understand why you would take it for more than 3 months! If you didn't adjust your eating habits, then no, it wouldn'[Show More]First off, this is not a "take it a year" diet medicine! I took it 7 years ago for 3 months, lost over 50 pounds and had just started back on it, due to putting some of it back on from lack of watching my own diet. The goal behind this diet pill is for short term use. I fail to understand why you would take it for more than 3 months! If you didn't adjust your eating habits, then no, it wouldn't work. I am totally angry that this medicine has been recalled due to lazy people who got so out of weight to begin with that they put themselves at risk, and now are blaming a medicine that helped those of us who followed our doctor's advice and took it not more than 3 months and corrected our own bad habits! Shame on those that eat themselves to death.

  • LaurenOctober 21, 2010 at 6:21 pm

    '@Tom- The FDA is a safeguard between the public and the drug companies. If the companies had their way, there would be no regulation and thousands of useless and potentially dangerous products on the market. I hate to think that someone would discredit the FDA so quickly, especially considering you have them to thank that the meds that you either take now or will in the future won't kill you and [Show More]'@Tom- The FDA is a safeguard between the public and the drug companies. If the companies had their way, there would be no regulation and thousands of useless and potentially dangerous products on the market. I hate to think that someone would discredit the FDA so quickly, especially considering you have them to thank that the meds that you either take now or will in the future won't kill you and actually WORK for the purpose it was intended

  • ForrestOctober 16, 2010 at 3:54 pm

    I had been taking Meridia for a year or more and on 10/30/2009 I had a stroke and the Doctors told me they could not determine the cause.

  • HelenaOctober 12, 2010 at 5:02 pm

    I started taking Meridia around June of this year. By September I knew something we very wrong. Meridia was not working as far as weight loss was concerned and I was just not feeling myself. Per the suggestion of my mail order pharmacist, I stopped taking it immediately. After I stopped taking the drug I began to feel better. I hate to think what could have happened if I continued to take Mer[Show More]I started taking Meridia around June of this year. By September I knew something we very wrong. Meridia was not working as far as weight loss was concerned and I was just not feeling myself. Per the suggestion of my mail order pharmacist, I stopped taking it immediately. After I stopped taking the drug I began to feel better. I hate to think what could have happened if I continued to take Meridia.

  • TomOctober 11, 2010 at 5:39 pm

    The FDA's job is to assure the public that the drugs they approve are "Safe and Effective", apparently using the following criteria:: Safe: Is the drug manufacturer likely to get sued? Effective: Will the drug manufacturer make loads of cash? "Safe and Effective": Do the chances of 'benefits' in the form of obscene profits outweigh the 'risks' of punishing lawsuits? After market, it became obvi[Show More]The FDA's job is to assure the public that the drugs they approve are "Safe and Effective", apparently using the following criteria:: Safe: Is the drug manufacturer likely to get sued? Effective: Will the drug manufacturer make loads of cash? "Safe and Effective": Do the chances of 'benefits' in the form of obscene profits outweigh the 'risks' of punishing lawsuits? After market, it became obvious that the "Efficacy" of Meridia was jeopardized by "Safety" concerns, meaning that the manufacturer was destined to lose money via lawsuits. Banning Meridia serves the interests of the manufacturer. The FDA has done its job.

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